Axumin (fluciclovine F 18 Injection)

Prostate cancer affects one in seven men in the US, up to a third treated for prostate cancer will experience recurrent disease, most often detected only by rising Prostate Specific Antigen (PSA) levels. Often the location and extent of the disease cannot be detected by conventional imaging in the early stages of recurrence. Although there is an ever-increasing number of treatment options, an estimated 26,100 men died of the disease in the US in 2016, generally after primary local and systemic treatments for prostate cancer failed. Current diagnostic measures are frequently unable to reliably detect the exact location(s) of disease relapse at a time when curative treatment is still possible.

Conventional imaging tools such as traditional FDG PET/CT scans and bone scans frequently fail to identify the site of recurrent disease when it comes to Prostate Cancer, presenting a serious challenge to urologists and radiation oncologists charged with the selection of secondary treatment, and causing significant anxiety for patients.

The Limits Of FDG-PET For The Detection Of Recurrent Prostate Cancer

FDG-PET is of limited use in Biochemical Recurrence because uptake in Prostate Cancer is generally suboptimal until the patient has metastatic castrate resistant disease. Physiologic excretion of FDG in the bladder may interfere with image interpretation of adjacent structures in the pelvis. Salvage Radiation Therapy (SRT) to the prostate should be initiated well before a PSA of 10 – 20 ng/mL is reached, as studies have demonstrated that outcomes are better if treatment is initiated at low (e.g.

Axumin (fluciclovine F 18 Injection) Approval

Enter Axumin™: On May 27, 2016, the FDA approved Axumin [fluciclovine F 18 Injection; Blue Earth Diagnostics Ltd, Oxford UK] for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. The approval of Axumin ushers in a new era of F18 PET/CT for the detection of recurrent prostate cancer in the USA. Data submitted to FDA included results from prospective studies at Emory University and the University of Bologna and from clinical use at two sites in Norway; the pooled data for n= 595 subjects were retrospectively analyzed. Overall, fluciclovine F 18 PET/CT detected sites of recurrence in 68% (403/595) of patients. For patients with baseline PSA values in the lowest quartile ( 1.78 ng/mL had a positive scan, of which 58 were confirmed as positive